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Arcellx Reports Positive Results from iMMagine‑1 Trial in Relapsed/Refractory Multiple Myeloma Patients
Arcellx reported Phase 2 iMMagine‑1 results for its CAR‑T therapy anito‑cel in relapsed/refractory multiple myeloma. Among 117 patients, the overall response rate reached 96% with 74% achieving complete or stringent complete responses; 95% of evaluable patients attained MRD negativity, 83% sustaining it >6 months. Twelve‑month progression‑free and overall survival were 82.1% and 94.0%, respectively, with median PFS/OS not yet reached. Safety was favorable, showing no delayed neurotoxicities. The company reaffirmed a 2026 U.S. launch in partnership with Kite, aiming for broader global rollout.
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Prelude Therapeutics Shares Findings from Its Myeloproliferative Neoplasm Programs at the 2025 ASH Annual Meeting
Prelude Therapeutics disclosed preclinical data at ASH 2025 on two MPN programs: PRT12396, a JAK2V617F‑selective JH2 inhibitor that outperforms ruxolitinib, has completed GLP toxicology and is slated for IND filing and Phase 1 in Q1 2026 under an exclusive Incyte option; and mutant CALR‑directed degrader antibody conjugates delivering a CDK9 degrader, which achieve deep, mutant‑selective cell killing in vitro and in vivo while sparing normal hematopoietic cells. Both remain preclinical.
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Early CARVYKTI® Use Leads to Durable 2.5‑Year Treatment‑Free Remission in Relapsed/Refractory Multiple Myeloma
Phase 3 CARTITUDE‑4 data show that a single infusion of CARVYKTI (ciltacabtagene autoleucel) given as second‑line therapy to standard‑risk multiple myeloma patients yields 80.5 % progression‑free survival at 30 months, with all MRD‑negative responders remaining disease‑free. Translational analyses link higher baseline CD4⁺ naïve T‑cells and an activated bone‑marrow microenvironment to improved outcomes. Safety remains consistent (84 % CRS, 13 % ICANS, low grade ≥3 rates). FDA approval now includes earlier‑line use, positioning CARVYKTI for broader market share and supporting future combination and allogeneic trials.
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Vertex Unveils New CASGEVY® Data—including First Results in Children Aged 5‑11—at ASH Annual Meeting, Announces Global Regulatory Plans
Vertex presented Phase 3 data showing CASGEVY’s efficacy and safety in children 5‑11 with severe sickle cell disease (SCD) or transfusion‑dependent beta thalassemia (TDT). All 11 SCD patients remained vaso‑occlusive‑crisis‑free for ≥12 months; 12 of 13 TDT patients achieved ≥12 months transfusion independence, with one fatal conditioning event. Results mirror those in patients ≥12 years. Vertex will file global supplemental BLAs in early 2026, aiming for accelerated review, expanding the first‑in‑class gene‑editing therapy to the pediatric market.
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Braemar Hotels & Resorts Moves 2025 Annual Meeting to a Virtual Format
Braemar Hotels & Resorts Inc. (BHR) will hold its 2025 Annual Meeting entirely online on Dec 15, 2025 at 9 a.m. CT, accessible via www.virtualshareholdermeeting.com/BHR2025. Proxy statements and the FY 2024 Form 10‑K are available on the investor section of www.bhrreit.com. The virtual format cuts venue and travel costs, leverages secure webcast technology for electronic voting, and expands global shareholder participation. BHR reported FY 2024 revenue of $1.2 billion with a 9% occupancy increase and projects 85% occupancy in 2025, highlighting a strategic focus on cost efficiency, technology adoption, and growth in luxury hospitality.
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Banyan Gold Issues Incentive Stock Options to Employees
Banyan Gold Corp. announced that its board approved 5,060,000 stock options to purchase 5.6 million shares at a $1.00 exercise price, vesting over up to 18 months and expiring after five years, granted to consultants, employees, advisors and exploration staff. The updated Aur Mac mineral‑resource estimate (effective 28 June 2025) reports 2.274 Moz indicated and 5.453 Moz inferred gold. The Hyland project (effective 1 Sept 2025) holds 337 koz indicated gold, 2.63 Moz indicated silver, plus 118 koz gold and 0.86 Moz silver inferred. Upcoming roadshows are scheduled for Toronto (8‑10 Dec 2025) and Houston (21‑23 Dec 2025).
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KALA BIO Completes $10 Million At-The-Market Direct Offering of Common Stock Under Nasdaq Rules
KALA BIO (NASDAQ:KALA) completed a registered direct offering on Dec 5 2025, selling 10 million common shares (or pre‑funded warrants) at $1.00 each, generating roughly $10 million in gross proceeds. H.C. Wainwright acted as exclusive placement agent. Net proceeds will be used to repay indebtedness and for general corporate purposes. The offering was executed under a shelf registration (File No. 333‑270263) filed Mar 3 2023 and became effective May 11 2023.
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Four Global Markets, One Engine: SMX Redefines What a Supply Chain Can Achieve
SMX (NASDAQ: SMX) markets a universal material‑identity engine that links gold, rare‑earths, digital‑asset platforms and ESG compliance. The platform preserves provenance from extraction to transformation, enabling the Plastic Cycle Token and auditable lifecycle data. Recent announcements triggered a 138% intraday surge, though the stock remains below its 200‑day moving average. Investors are watching adoption in precious‑metal and mineral supply chains, token issuance, and regulatory approvals. Risks include integration challenges, regulatory adoption, capital needs and competition.
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BrandPilot AI Completes Debt Settlement and Issues Options and Restricted Share Units
BrandPilot AI settled a $17,272.75 liability by issuing 690,910 Debt Settlement Units—each containing a common share and a warrant exercisable at $0.05 for up to 24 months—at a deemed $0.025 per unit, with a 4‑month‑plus‑1‑day hold. Simultaneously, it granted 2.8 million stock options (exercise $0.05, three‑year vest, exercisable through Dec 1 2030) and 5.05 million RSUs (vesting Dec 1 2028). All awards were made under the omnibus equity incentive plan approved on May 31 2024, aiming to preserve cash and align executive compensation with growth.
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.AeroVironment Appoints Milancy Harris as Vice President and Chief Security Officer
.AeroVironment announced the appointment of Milancy Harris as Vice President and Chief Security Officer. Harris, former Acting Under Secretary of Defense for Intelligence and Security, will lead an enterprise‑wide security strategy to protect the company’s people, programs, and technologies. Her expertise is expected to bolster cyber‑physical risk management, support compliance with defense security standards, and enhance investor confidence amid growing modernization spending. Strengthening security governance aligns AeroVironment with the Pentagon’s zero‑trust mandate, potentially lowering insurance costs, improving contract win rates, and safeguarding its AI‑driven autonomous systems and emerging directed‑energy platforms.